Introduction
Scenario: Dr. Smith’s patient, Michael, has been diagnosed with colon cancer and is seeking to participate in a clinical trial that offers hope of a new treatment for his medical condition. Dr. Smith considers the trials she is familiar with at her hospital and manually reviews Michael’s medical history against the trial criteria – determining that he is not a match. This process is laborious and sometimes error prone – especially when required data is not fully accessible. In Michael’s case, Dr. Smith could not consider his full medical history as he’d recently moved to the area. Together, these challenges mean that neither Michael nor Dr. Smith are aware that there’s a potential trial at another hospital across town. As a patient, Michael is able to conduct a search on his own, however this entails a highly manual process, clinical trial data from various tools is not always up-to-date and can quickly become overwhelming. Given the complexities of this process, Michael is eventually ‘matched’, but it is too late – the desired trial has closed enrollment.Questions to Address:
CodeX and Vulcan – HL7 FHIR Accelerators
CodeX
Established in 2019, CodeX is a community of people who are engaged in clinical specialties in the areas of oncology, genomics and cardiology with an aim to break down data silos to improve patient care and clinician experience.Codex is tackling standardized patient medical records to ensure the data needed for trial matching is readily available.
Vulcan
The Vulcan FHIR Accelerator was launched in 2020. It is a global user community leveraging FHIR to enable the integration of research into the delivery of healthcare to improve patient lives, decrease costs and increase efficiency. Vulcan is maturing the necessary FHIR resources to broaden the use of EHR data by the research community at large.Vulcan is developing the exchange standard (FHIR IG) for digital protocols, enabling searchable clinical trial criteria that can improve efficiency and accuracy of trial matching.
The Codex and Vulcan communities are similar in composition, with academic health centers, government, biopharmaceutical companies, software/technology providers and other stakeholders sharing a strong dedication to developing standards to improve healthcare for patients, clinicians and research. Read further to understand each Accelerator’s complementary approach to the unique challenges of trial matching.
What Are We Doing About Trial Matching?
CodeX
CodeX has established a set of optimized patient data elements to pre-screen patients for cancer clinical trials (mCODE) and convened stakeholders to evaluate a new tool, Blue-button, leveraging mCODE to automate regional clinical trial matching.
WHAT:
“Blue-button” - a tool that automatically identifies relevant regional clinical trials through one-button clinical trial matching service integration within the electronic health record (EHR).
HOW:
Blue-button connects EHRs to existing trial matching services and integrates clinical trial matching function into the workflow of care teams.
IMPACT:
This allows accurate, comprehensive and automated pre-screening at the point of care. In addition, using third-party services allows the tool to look for matching clinical trials within a specific distance from the patient’s location – expanding the patient’s options beyond just a limited number of healthcare institutions.
A prospective study is underway to evaluate whether Blue-button can increase and diversify clinical trial participation with minimal effort on the part of providers.
Vulcan
Vulcan has convened relevant stakeholders to form the Utilizing the Digital Protocol (UDP) project, collaborating to develop an HL7 FHIR Implementation Guide (IG) enabling the exchange of protocol details in a standardized, unambiguous, digital format.
WHAT:
Under development – an HL7 FHIR Implementation Guide (IG) defining the standardized exchange of clinical protocol information.
HOW:
Vulcan will convene stakeholders to bring together complementary work products to achieve this vision. ICH M11’s CeSHarP template and CDISC’s Unified Study Definition (USDM) will serve as underlying domain and information models. Prior Vulcan work in defining the exchange standard for a portion of the protocol will enable several downstream use cases.
IMPACT:
A digitalized protocol allows unambiguous interpretation of its contents and opens the possibility for many downstream use cases – with full integration of the protocol into a site’s patient management system as an example.
Specific to trial matching, enabling a global standard for digital representation of trial criteria will provide Trial Sponsors, Regulators, EHR Vendors, Trial Matching Services and Patients a common mechanism for searching against these trial requirements.
CodeX
Better Data. Better Health. Stay connected with the CodeX community.
Vulcan
Bring clinical research to the point of care. Partner with Vulcan to contribute to the utility and adoption of the digital clinical protocol.
May HL7 Connectathon
Both technical and non-technical participants are encouraged to join to ensure the FHIR IG aligns with real-world implementation needs and use cases. See firsthand how trial criteria and protocol data can be structured and shared efficiently. Gain insights into tools and methods that make trials more scalable, interoperable and future proof. Learn more here.
Register here. Early bird registration is available through Friday, April 18, 2025.
Join the UDP Efforts
Stay Tuned!
Read Part 2 next week for an in-depth discussion of the current status of trial matching and the vision for an interoperable future state.